Parenteral solution container



Nov. 2, 1965 s. COANDA ETAL PARENTERAL SOLUTION CONTAINER 2 Sheets-Sheet 1 F IG. 2.

Filed Sept. 11. 1961 FIG.

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7 3w 8 4 m0 mm V 0 M n 3. m m F 0 2 NOV. 1965 e. COANDA ETAL 3,215,299

PARENTERAL SOLUTION CONTAINER Filed Sept. 11, 1961 2 Sheets-sheet 2 FIG. 5.

/I II II II I) [III/II A INVEN TORS 650M? MAI/0A 551M 0. F01 III/.40

United States Patent 3,215,299 PARENTERAL SOLUTION CONTAINER George Coanda, North Hollywood, and Bern D. Folkman,

Glendale, Califl, assignors to Don Baxter, Inc., Glendale, Califl, a corporation of Nevada Filed Sept. 11, 1961, Ser. No. 137,336 6 Claims. (Cl. 215-100) This invention relates to plastic parenteral solution containers, and particularly to suspension and closure means for such containers.

Parenteral solutions such as dextrose, saline, electrolyte mixtures, blood, and blood plasma are now usually provided in containers made of glass. While quite satisfactory in many ways, such containers are fragile, heavy, and expensive. Because-of their cost the containers are often re-used. Occasionally an opening, such as a crack or pinhole, may develop in the container wall, and these are very difficult to detect. Such openings are undesirable in any container, but they are most serious in a container for sterile, parenteral solutions which are to be injected into human patients.

Plastic bags, the walls of which collapse against each other in the absence of fluid, have been proposed as parenteral solution containers. However, such containers are difficult to seal, and defective seals and pinholes near the seals are a serious problem. In use, it is sometimes necessary to interrupt the administration of a solution to administer blood. In this case the administration apparatus is disconnected from the solution container, leaving the outlet of the solution container open. In the case of a plastic bag the walls of which are not selfsupporting, the remaining solution will flow through the open outlet when the container is placed on a flat surface. Also, the lack of rigidity makes handling of the empty, collapsed containers diflicult and special machines must be used for production filling operations.

In recent years, blow-molded plastic containers have been suggested for many uses. Such containers have walls which are thin, flexible, and deformable, but which are self-supporting. Containers of this type are frequently referred to as squeeze bottles because they are normally expanded, but can be collapsed by external pressure. Blow-molded containers have been used for parenteral solutions, but the closures of such containers leave much to be desired. Some of these closures tend to leak, other difiicult and expensive to assemble under production conditions, and still others are difficult or inconvenient to enter with an administration set to administer the parenteral solution.

For administration of parenteral solutions, the blowmolded containers must be provided with suspension devices, and these have also been unsatisfactory. Some such devices prevented the container from standing on a flat surface, others were so small they required the attachment of a separate supplementary extension, while still others unduly complicated the design and production of the containers.

It is, therefore, an object of this invention to provide a parenteral solution container of the blow-molded or squeeze bottle type having an inexpensive closure which iseasy to assemble and to use.

Another object of the invention is to provide a parenteral solution container having an improved, inexpensive suspension device.

Further. objects and advantages of the invention will be apparent from the examples described in the following specification and shown in the drawings, in which:

FIGURE 1 is an elevational view, partially cut away, of .the container in inverted position ready to be suspended for administration of its contents;

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FIGURE 2 is a plan view of the base of the container;

FIGURE 3 is an enlarged sectional view on the line 3-3 of FIGURE 1;

FIGURE 4 is a further enlarged sectional view of the outlet closure before attachmentto the container;

FIGURE 5 is an enlarged sectional view showing the outlet closure placed loosely on the container neck prior to sealing;

FIGURE 6 is an enlarged sectional view showing details of the sealed closure and cap shown in FIGURE 1;

FIGURE 7 is a still further enlarged sectional view on the line 7-7 of-FIGURE 2; and

FIGURE 8 is a view similar to FIGURE 4, but showing a modified form of the outlet closure.

Referring now to the drawings, the parenteral solution container 10 has a body 11, preferably having flexible, generally rectangular side walls 17a, 17b, 17c, and 17d, and a generally rectangular transverse cross section. Graduations 12 run lengthwise and may be printed on or molded into the side wall 17c. At one end, the sides of the body join into a relatively stilt shoulder section 13 which slants upwardly toward the center of the container at an angle of about 15. A rigid tubular neck 14 projects axially from the center of shoulder section 13, providing an outlet opening 15 sealed by a closure 16.

Container body 11 is preferably made of;polypropylene plastic by extrusion blow-molding. In this process, a tubular parison is extruded and is then blown in a mold of the desired shape and size. The wall thickness of such containers varies, but we have found that the vouter surface of neck 14 can be precisely shaped and dimensioned. Plastics other than polypropylene may also be used. However, polypropylene is the preferred plastic because it is heat sterilizable, remarkably compatible with solution ingredients, and provides the strength necessary for the suspension device to be subsequently described.

When container body -11 is formed of polypropylene, a one-liter container may have a Weight of approximately 25 to 30 grams as compared to approximately 650 grams for an ordinary glass container. The flexible side walls of body 11 are preferably from about 0.015 to 0.030 inch thick. The relatively thick bottom and top sections taper from about 0.030 inch adjacent the side walls to about 0.10 inch near the center, and thus are quite stiff and rigid. The wall of tubular neck 14 may also be about 0.10 inch thick. This wall thickness plusthe additional strength and stiffness of the small diameter tube results in a stiff, virtually unfiexible neck.

The cap-like closure 16 can be formed by either injection molding or vacuum forming, and is preferably made of polypropylene. Closure 16 has a disc-like body 20 having an inner surface '21 adapted to seat on the annular end surface of neck 14. An annular skirt22 projects from body 20 and has a circumferential surface 23 facing radially inwardly and an ,end surface 24. Near the center of body 20, a thin-walled tube 25, generally concentric with skirt 22, projects axially 'into container neck 14. Theend of tube 25 adjacent body 20 is open, while the other end is closed by a thin, pierceable diaphragm 27 which preferably has a thickness of 0.005 to 0.015 inch. Tube 25 is substantially smaller indiameter than the inside of neck 14, thus providing a space 28 between the tube and neck 14.

As best shown in'FIGURES 5 and 6, skirt 22 of closure 16 is shaped to fit snugly around the outer surface of tubularneck 14. After. the container is filled with solution, closure .16 is placed on neck 14 and-skirt 22 heatsealed to the outer surface of the neck 14. This is preferably accomplished by placing a heated tool over skirt 22 and pressing the tool down over closure 16. The tool may advantageously be cool when put in place and may then be heated by electrical induction. The inwardly facing circumferential surface of the tool should be generally cylindrical and should be smaller than skirt 22 so as to press the skirt radilly inwardly against the outer surface of neck 14. Preferably, the inwardly facing circumferential surface of the tool tapers axially inwardly toward the top so as to reform the outer surface of skirt 22 to a frusto-conical shape having its smaller base adjacent body 20. This provides a strong, leakproof seal so that closure 16 will not break loose when pierced by an administration set connector, as will subsequently be described.

An outer cap 29, having a disc-like head 62, covers closure 16 and maintains diaphragm 27 and the tube bore 26 in a clean, sterile condition. A thin-walled flexible skirt 63 extends from head 62 and is adapted to fit around the outer surface of closure skirt 22 and neck 14 after they are sealed together. Skirt 63 has an annular reinforcing ring 64 around one end and longitudinal ribs 65 spaced around its circumferential surface. A hollow tube 66 extends axially from the inner surface of head 62 and fits tightly into bore 26 of closure tube 25. The seal thus formed is surprisingly effective and cap 29 can be used to reseal the container temporarily during an emergency switch to blood.

The base of body 11, generally indicated as 32, has two protuberant base sections 32a and 32b separated by a centrally located recess. At one side of the recess, a wall 33 extends longitudinally inward between the center of base 32 and side wall 17a. Wall 33 is generally parallel to side wall 17a, but tapers away from said side wall toward the center of base 32 to make the recess narrower in the center than at the ends. A second wall 34 extends longitudinally inward between the center of base 32 and side Wall 1711 to form the other side of the recess. Walls 33 and 34 are connected by an indented base wall 35 which is spaced inwardly from base sections 32a and 32b, and which slants progressively away from the base sections as it approaches side walls 17d and 170. Thus, a slot-like recess is formed by walls 33, 34 and indented base wall 35. This recess preferably extends completely across base 32 so that the mold in which the container is formed can open without raising the container.

A thin, flexible web 36 is formed as an integral, onepiece extension of indented base wall 35 which projects into the recess. At the sides, web 36 is disconnected from walls 33 and 34 as by the cuts 44, 45. A suspension tab 37 is formed as an integral one-piece extension of web 36 and projects therefrom. Tab 37 is preferably thicker and more rigid than web 36 and has an aperture 38, suitable for receiving a hook or other hanging device. A particularly suitable suspension device can be formed of polypropylene by making web 36 approximately 0.010 to 0.020 inch thick.

As shown in FIGURES 2 and 3, suspension tab 37 preferably is quite large and in its extended position, extends from indented base wall 35 out of the slot-like recess and beyond the protuberant base sections 32a, 32]). It should be noted, however, that web 36 may easily be bent to allow tab 37 to reciprocate in and out of the recess defined by walls 33, 34 and 35. Also, web 36 can be provided with a permanent set in the bent position so that tab 37 normally lies in the recess until lifted out. Details of this process will be described subsequently. Thus, the container can be placed base down on a table and will stand upright with suspension tab 37 folded down into the recess as shown by the dotted lines in FIGURES 2 and 3. Tab 37 is also preferably folded down during shipping so that the container occupies a minimum of space. If desired, directions for used, sterile swabs, and other items of auxiliary equipment can be fastened in the recess with a piece of adhesive tape.

As shown in FIGURES 2 and 7, base 32 is also provided with four protuberances or feet 39, 40, 41, and 42 projecting outwardly therefrom. An indented or depressed area 43 is provided in base 32 as an air inlet and is covered with a tape cover 46 held in place by a layer of pressure-sensitive adhesive. The container wall at the base of depressed area 43 serves as a puncturable diaphragm as will be described subsequently. It may have the same thickness as the adjacent wall of base 32a, but is preferably thinner to facilitate puncture.

FIGURE 8 shows a modified form of closure fitment 49 which does not require an outer cap. Closure fitment 49 has a disc-like body 50 having an inner surface 51 against which the annular end surface of a tubular container neck seats. A skirt 52 extends at approximately right angles from the periphery of body 50, terminating in an end 54 and providing an inner skirt surface 53 which is sealed to the outer surface of the container neck. A centrally located tube projects from body 50 and is concentric with skirt 52. The tube has a bore 56 which is closed by a diaphragm 57 at the end adjacent body 50 and which is open at the end spaced from body 50. In the center of diaphragm 57 an indentation provides a thin pierceable wall portion 58.

In use, the modified closure fitment shown in FIGURE 8 usually is swabbed across the top surface of body 50 with an antiseptic solution. The connecting spike of an adminstration set is then forced through diaphragm 57 and telescoped into tube 56. During this step care must be taken to hold the container by the rigid neck 14 and shoulder section 13. If the container is held by the flexible walls 17 pressure is developed in the container with consequent leakage around the connecting spike as the spike pierces diaphragm 57 and before it seals with the bore wall 56.

In the manufacture of parenteral solutions, the molded container bodies 11 are washed, rinsed, and then filled with a suitable solution, such as dextrose or saline. A closure 16 or 49 is then placed over the neck of the container and the inner surface 23 or 54 heat-sealed to the outer surface of neck 14, as previously described. The containers of solution are then placed in an upright position in an autoclave and sterilized by steam under pressure. During sterilization, the containers are preferably supported on the indented base wall 35 and may be held in position by neck 14. Suspension tab 37 should be bent down against base wall 35 so as to give web 36 a permanent set with tab 37 completely within the base recess until it is deliberately lifted out.

Alternatively, the empty container can be heated with suspension tab 37 bent down against base wall 35 to provide web 36 with a permanent set. The container and solution can then be separately sterilized by any suitable means and the sterile solution filled into the sterile container.

In use, cap 29 is removed from closure 16. The spike of an administration set is then telescoped into tube 25, piercing diaphragm 27 and deforming the thin wall of tube 25 outward. Suitable administration set spikes are known in the art, as for example those shown in United States Patents 2,954,768, 2,784,733, 2,730,097, and 2,912,- 980. As the connecting spike of the administration set is telescoped into tube 25, the outer surface of the spike seals with the bore wall 26 just prior to piercing of diaphragm 27. This prevents fluid from leaking out past the connecting spike and also assures firm attachment of the administration set to the container. Suspension tab 37 is then lifted out of the base recess and the end of a hook or other hanging device passed through aperture 38. When body 11 is formed of polypropylene, as previously de scribed, bending of web 36 orients the polymer molecules and increases the strength of the web. For this reason, web 36 can be bent innumerable times without breaking or cracking.

As fluid is withdrawn from container 10, the pressure of the surrounding atmosphere collapses the flexible side walls inwardly so that most of the fluid can be removed. In some cases however, it may be desirable to administer all of the fluid or to increase the rate of administration. This can be done by providing an inlet passage in the base through which air can enter the container. Such a passage is conveniently provided by removing tape 46 from the indented area 43 and piercing the diaphragm at the base of indented area 43 with a spike or hypodermic needle, which preferably is provided with a cotton pledget or other air filter.

If it is necessary to disconnect the solution in order to administer blood or other emergency medication, the spike of the administration set can be removed from c1osure tube 25 and container set base down on a table or shelf. Since diaphragm 27 has been pierced, the container is preferably closed by replacing cap 29 over closure 16. When cap 29 is pressed down firmly against closure 16 a surprisingly effective seal is formed. We have found that this seal is sufficient to withstand considerable pressure on the container side walls, even though diaphragm 27 is pierced.

While we have shown and described certain embodiments of our invention, it should be understood that many changes and modifications can be made without departing from the spirit and scope of our invention, as described in the appended claims.

We claim:

1. A parenteral solution container comprising: a plastic body; a rigid tubular neck on said body; an outlet opening on at least one end of said neck; a closure having a disclike body closing said outlet opening; a skirt projecting from said closure body and telescoped over the outside of the tubular container neck, the inner surface of said skirt being sealed to the outer surface of the container neck; an integral base on said body, said base including protuberant base sections adapted to rest on a flat surface and an indented base wall spaced from the base sections to form a recess; a thin, flexible web forming an integral unit with the indented base wall and extending therefrom; and a suspension tab integral with said web and extending beyond the protuberant base sections.

2. A parenteral solution container comprising: a plastic body; an integral base on said body, said base including protuberant base sections adapted to rest on a flat surface and an indented base wall spaced from the base sections to form a recess; a thin, flexible Web forming an integral, one-piece unit with the indented base Wall and extending into the recess; and a suspension tab forming an integral one-piece unit with said web and extending beyond the base sections.

3. A parenteral solution container as set forth in claim 2 wherein the protuberant base sections are provided with a plurality of protruding, thin-walled feet, the recess extends completely across the base, the indented base Wall slants progressively toward a centrally located apex line constituting the part of the indented base wall closest to the protuberant base sections, and the web meets the base along said apex line.

4. A parenteral solution container asset forth in claim 2 wherein the web is normally bent so that the tab normally lies within the base recess.

5. A parenteral solution container as set forth in claim 2 wherein the body is formed of polypropylene plastic and the body, the web, and the suspension tab form an integral, one-piece structure.

6. A parenteral solution container comprising: a plastic body having thin, flexible, self-supporting side walls and a generally square transverse cross section; a relatively thick, stiff base on said body, said base including protuberant base sections and an indented base wall spaced from said base sections to form a recess across the base; longitudinal walls on each side of the indented base wall connecting said wall to the base sections and defining the sides of the recess; a thin, flexible Web forming an integral, one-piece extension of the indented base wall and projecting into the recess; and a thick, stiff suspension tab forming an integral, one-piece extension of said web and projecting beyond the protuberant base sections, said web having a permanent set whereby the web is normally bent so the tab lies within the recess, but can be straightened so that the tab extends axially from the container base beyond the protuberant base sections.

References Cited by the Examiner UNITED STATES PATENTS 2,642,870 6/53 Smith l28-272 2,679,875 6/54 Baldanza 1500.5 2,693,189 11/54 Ryan 128-272 2,876,818 3/59 Raff et al ISO-0.5 2,880,722 4/59 Dickenson 128214 2,951,264 9/60 Bailey l8-55 2,967,330 1/ 61 Tommarchi l855 3,092,106 6/63 Butler 128214 FOREIGN PATENTS 204,912 8/59 Austria. 1,240,728 8/ France. 1,250,850 12/60 France. 1,255,886 1/61 France.

FRANKLIN T. GARRETT, Primary Examiner.

WALTER A SCHEEL, GEORGE O. RALSTON,

Examiners, 

1. A PARENTERAL SOLUTION CONTAINER COMPRISING: A PLASTIC BODY; A RIGID TUBULAR NECK ON SAID BODY; AN OUTLET OPENING ON AT LEAST ONE END OF SAID NECK; A CLOSURE HAVING A DISCLIKE BODY CLOSING SAID OUTLET OPENING; A SKIRT PROJECTING FROM SAID CLOSURE BODY AND TELESCOPED OVER THE OUTSIDE OF THE TUBULAR CONTAINER NECK, THE INNER SURFACE OF SAID SKIRT BEING SEALED TO THE OUTER SURFACE OF THE CONTAINER NECK; AN INTEGRAL BASE ON SAID BODY, SAID BASE INCLUDING PROTUBERANT BASE SECTIONS ADAPTED TO REST ON A FLAT SURFACE AND AN INDENTED BASE WALL SAPCED FROM THE BASE SECTIONS TO FORM A RECESS; A THIN, FLEXIBLE WEB FORMING AN INTEGRAL UNIT WITH THE INDENTED BASE WALL AND EXTENDING THEREFROM; AND A SUSPENSION TAB INTEGRAL WITH SAID WEB AND EXTENDING BEYOND THE PROTUBERANT BASE SECTIONS. 